Trial Outcomes & Findings for Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma (NCT NCT00841555)

Last Updated: 2018-04-18

Results Overview

This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels will be recommended for phase II evaluations of treatment effect.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

up to 12-16 months

Results posted on

2018-04-18

Participant Flow

Patients were enrolled between 2009 and 2012

Participant milestones

Participant milestones
Measure	Dose Level 1: 50 mg/m2 Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT	Dose Level 2: 65 mg/m2 Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT	Dose Level 3: 75 mg/m2 Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT
Overall Study STARTED	3	3	3
Overall Study COMPLETED	3	3	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: up to 12-16 months

Outcome measures

Outcome measures
Measure	Hypofractionation Radiotherapy+Temozolomide n=9 Participants Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT
Maximum Tolerated Dose(MTD)of Temozolomide(TMZ)	75 mg/m^2

SECONDARY outcome

Timeframe: up to 12-16 months

As a small phase I study, no inferential statistical tests of hypotheses are planned. Data collected will be providing descriptive summary statistics. However, these estimates will allow statistically sound experimental designs and sample size calculations for subsequent studies of therapeutic effect.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years

All patients will be followed to death. Active follow-up with disease evaluation with scans will be terminated if the patient's physician deems it in the patient's interest not to continue or upon patient request.

Outcome measures

Outcome measures
Measure	Hypofractionation Radiotherapy+Temozolomide n=9 Participants Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT
Survival Time	12.7 months Interval 2.5 to 17.6

SECONDARY outcome

Timeframe: up to 12-16 months

Population: Kaplan-Meier analysis for time spent in a Karnofsky performance status (KPS) ≥70

Time spent in a KPS ≥70 was calculated from the date of diagnosis of Karonofsky Performance Status decline (KPS\<70) or censored at the last date the patient was known with KPS ≥70. The KPS higher scores indicates normal activity status.

Outcome measures

Outcome measures
Measure	Hypofractionation Radiotherapy+Temozolomide n=9 Participants Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT
Time Spent in a Karnofsky Performance Status of 60-100%	8.1 months Interval 2.4 to 15.6

Adverse Events

50 mg/m2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

65 mg/m2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

75 mg/m2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Mario Ammirati, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-1970

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dose Level 1 n=3 Participants Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT	Dose Level 2 n=3 Participants Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT	Dose Level 3 n=3 Participants Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	3 patients n=5 Participants	3 patients n=7 Participants	3 patients n=5 Participants	9 patients n=4 Participants

Measure	50 mg/m2 n=3 participants at risk Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT	65 mg/m2 n=3 participants at risk Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT	75 mg/m2 n=3 participants at risk Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT
General disorders Fatigue	100.0% 3/3 • Number of events 3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	66.7% 2/3 • Number of events 2 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	66.7% 2/3 • Number of events 2 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	66.7% 2/3 • Number of events 2 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	66.7% 2/3 • Number of events 2 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	100.0% 3/3 • Number of events 3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Nervous system disorders Partial seizure	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Nervous system disorders Motor deficits	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Nervous system disorders Numbness	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Nervous system disorders Somnolence	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Eye disorders Vision changes	66.7% 2/3 • Number of events 2 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	66.7% 2/3 • Number of events 2 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Nervous system disorders Memory deficits	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Psychiatric disorders Confusion	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Infections and infestations Oral candidiasis	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Renal and urinary disorders Incontinence	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Gastrointestinal disorders Stomach cramps	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Investigations High ALT	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	66.7% 2/3 • Number of events 2 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Metabolism and nutrition disorders Low Calcium	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Metabolism and nutrition disorders High gluclose	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Injury, poisoning and procedural complications Thrombocytopenia	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Blood and lymphatic system disorders Anemia	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	33.3% 1/3 • Number of events 1 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.	0.00% 0/3 The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.